EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

European Journal of Pharmaceutical and Medical Research (EJPMR) has indexed with various reputed international bodies like : Google Scholar , Indian Science Publications , InfoBase Index (In Process) , SOCOLAR, China , Research Bible, Fuchu, Tokyo. JAPAN , International Society for Research activity (ISRA) , Scientific Indexing Services (SIS) , Polish Scholarly Bibliography , Global Impact Factor (GIF) (Under Process) , Universal Impact Factor , International Scientific Indexing (ISI), UAE , Index Copernicus , CAS (A Division of American Chemical Society) USA (Under Process) , Directory of Open Access Journal (DOAJ, Sweden, in process) , UDLedge Science Citation Index , CiteFactor , Directory Of Research Journal Indexing (DRJI) , Indian citation Index (ICI) , Journal Index (JI, Under Process) , Directory of abstract indexing for Journals (DAIJ) , Open Access Journals (Under Process) , Impact Factor Services For International Journals (IFSIJ) , Cosmos Impact Factor , Jour Informatics (Under Process) , Eurasian Scientific Journal Index (ESJI) , International Innovative Journal Impact Factor (IIJIF) , Science Library Index, Dubai, United Arab Emirates , Pubmed Database [NLM ID: 101669306] (Under Process) , IP Indexing (IP Value 2.40) , Web of Science Group (Under Process) , Directory of Research Journals Indexing , Scholar Article Journal Index (SAJI) , International Scientific Indexing ( ISI ) , Scope Database , Academia ,

ISSN 2394-3211

Impact Factor: 7.065

ICV - 79.57

Abstract

REGULATORY HARMONIZATION IN GLOBAL CLINICAL TRIALS: PROGRESS AND CHALLENGES.

Madiha Naaz*

ABSTRACT

Regulatory harmonization in global clinical trials is a multifaceted endeavor that seeks to align regulatory requirements and standards across different regions and countries. This paper examines the progress made in regulatory harmonization efforts and the challenges that persist in achieving this harmonization. The study explores the impact of differing regulatory requirements, ethical considerations, data privacy concerns, and the influence of political and economic factors on the harmonization process. It also discusses emerging technologies, patient-centric approaches, and evolving regulatory frameworks that shape the future of regulatory harmonization. Ultimately, this research underscores the importance of continued collaboration and adaptation to realize the full potential of regulatory harmonization in advancing global healthcare.

Keywords: Regulatory harmonization, global clinical trials, regulatory requirements, ethical considerations.

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